There were 100 of emails going back and forth and dozens of face to face meetings over five years. Then the FDA said concluded that this isn’t working and sent that letter.
Reading the letter it’s interesting that the letter doesn’t even forbid 23andMe from diagnosing people. It forbids them from marketing that they are diagnosing people.
The letter for example says:
The Office of In Vitro Diagnostics and Radiological Health (OIR) has a long history of working with companies to help them come into compliance with the FD&C Act. Since July of 2009, we have been diligently working to help you comply with regulatory requirements regarding safety and effectiveness and obtain marketing authorization for your PGS device.
[...]
You have not worked with us toward de novo classification, did not provide the additional information we requested necessary to complete review of your 510(k)s, and FDA has not received any communication from 23andMe since May. Instead, we have become aware that you have initiated new marketing campaigns, including television commercials that, together with an increasing list of indications, show that you plan to expand the PGS’s uses and consumer base without obtaining marketing authorization from FDA.
If I want to judge whether or not the FDA is reasonable in this instance than I don’t have enough data.
You know that you could have checked Google, right? X-/
The letter.
There were 100 of emails going back and forth and dozens of face to face meetings over five years. Then the FDA said concluded that this isn’t working and sent that letter.
Reading the letter it’s interesting that the letter doesn’t even forbid 23andMe from diagnosing people. It forbids them from marketing that they are diagnosing people.
The letter for example says:
If I want to judge whether or not the FDA is reasonable in this instance than I don’t have enough data.